MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for ENVELLA BED P0819A manufactured by Hill-rom, Inc..
[101784306]
Patient Sequence No: 1, Text Type: N, H10
[101784307]
Nursing reported baxter sigma infusion pump repeatedly alarming ec 341 while connected and infusing to a patient who was in a hill-rom envella bed. Nursing's response was to switch out the pumps when this occurred, but the problem persisted. The pumps were connected to the ac outlet in the patient's room. Additionally, the patient reported being shocked when touching a metal object (nursing call bell, chain on the hill-rom trapeze hanging over his bed). Medical engineering downloaded the pump's history and saw the ec 341 error repeatedly. The engineer ran three pumps together in the patient's room using a demo set in each pump. The pumps ran for an hour without alarming. Nursing then connected one of the pumps to the patient in the envella bed, and within ten minutes, the pump started to alarm and displayed the ec 341 error. An electrical safety check was performed on the bed, and the bed passed. ====================== manufacturer response for bed, envella (per site reporter). ====================== hill-rom sent us the attached document on electrostatic discharge. ====================== manufacturer response for infusion pump, sigma (per site reporter). ====================== baxter issued a file number and requested that we return the pump. Facility has declined, as it affects multiple pumps and the pump functions properly when not attached to a patient in an envella bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7321207 |
| MDR Report Key | 7321207 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-02-20 |
| Report Date | 2018-02-28 |
| Date Reported to FDA | 2018-02-28 |
| Date Reported to Mfgr | 2018-02-28 |
| Date Added to Maude | 2018-03-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENVELLA BED |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-03-07 |
| Model Number | P0819A |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |